AART CALF IMPLANT

Elastomer, Silicone Block

AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Aesthetic And Reconstructive Technologies, Inc. with the FDA for Aart Calf Implant.

Pre-market Notification Details

• Device ID: K022511
• 510k Number: K022511
• Device Name: AART CALF IMPLANT
• Classification: Elastomer, Silicone Block
• Applicant: AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. 5871 LONE PINE PLACE Paso Robles, CA 93446
• Contact: Catherine Riple
• Correspondent: Catherine Riple; AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. 5871 LONE PINE PLACE Paso Robles, CA 93446
• Product Code: MIB
• CFR Regulation Number: 874.3620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-07-30
• Decision Date: 2002-08-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B4905021012C0	K022511	000
B4905021052C0	K022511	000
B490502105B0	K022511	000
B4905021062A0	K022511	000
B490502106A0	K022511	000
B490502106B0	K022511	000
B4905021072A0	K022511	000
B490502107A0	K022511	000
B4905022012C0	K022511	000
B490502201B0	K022511	000
B490502104C0	K022511	000
B490502104B0	K022511	000
B4905021042C0	K022511	000
B490502101B0	K022511	000
B490502101C0	K022511	000
B4905021022C0	K022511	000
B490502102B0	K022511	000
B490502102C0	K022511	000
B49050210321A0	K022511	000
B4905021032C0	K022511	000
B490502103B0	K022511	000
B490502103C0	K022511	000
B490502201C0	K022511	000
B4905022022C0	K022511	000
B4905023052E0	K022511	000
B490502305E0	K022511	000
B4905023062E0	K022511	000
B490502306E0	K022511	000
B4905023072E0	K022511	000
B490502307E0	K022511	000
B4905023082E0	K022511	000
B490502308E0	K022511	000
B4905023092E0	K022511	000
B490502304E0	K022511	000
B4905023042E0	K022511	000
B490502303E0	K022511	000
B490502202B0	K022511	000
B490502202C0	K022511	000
B4905023002E0	K022511	000
B490502300E0	K022511	000
B4905023012E0	K022511	000
B490502301E0	K022511	000
B4905023022E0	K022511	000
B490502302E0	K022511	000
B4905023032E0	K022511	000
B490502309E0	K022511	000